CompletedNot Applicable

Physical Cold Atmospheric Plasma for the Treatment of Cervical Intraepithelial Neoplasia

Germany63 participantsStarted 2017-09-01

Plain-language summary

Cervical intraepithelial neoplasia will be treated with physical low temperature plasma in the plasma cohort compared to watchful waiting in the control cohort. Primary endpoint after 3-6 months: Pathological remission. Secondary endpoint: HPV remission.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for CAP: * Histologically confirmed CIN I / II * Reliable assessment of the radius of the portio and marginal borders of the lesions * Written consent for treatment with low temperature plasma after reconnaissance Inclusion Criteria for Control-Group: * Histologically confirmed CIN I / II * Reliable assessment of the radius of the portio and marginal borders of the lesions * Patients who want a waiting procedure and a control examination after 3-6 months Exclusion Criteria: * Histologically confirmed CIN III * Not fully visible transformation zone * An indication of invasive disease * Expected lack of compliance of the patient or incapacity of the patient to understand the meaning and purpose of the clinical trial * Severe cardio-vascular disease * Lack of patient consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological remission of cervical intraepithelial neoplasia

Timeframe: 3-6 months

Trial details

NCT IDNCT03218436

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials